Quinazoline derivatives are known from the prior art as active substances for example for the treatment of tumoral diseases and also diseases of the lungs and airways. Processes for preparing quinazoline derivatives are described in WO03082290 and WO07068552. WO2009098061 discloses the base (compound (II)) of the fumarate salt according to the invention (compound (I)).
The aim of the present invention is to provide a salt of 9-[4-(3-chloro-2-fluoro-phenylamino)-7-methoxy-quinazolin-6-yloxy]-1,4-diaza-spiro[5.5]undecan-5-one which by virtue of its pharmaceutical efficacy as a tyrosine-kinase inhibitor is suitable for use in the therapeutic field, i.e. for the treatment of pathophysiological processes that are caused by the hyperfunction of tyrosine-kinases.
The compound prepared in the present invention is supposed to meet the requirements for physical and chemical stability and other properties, such as for example adequate solubility, that are imposed on an active substance of a medicament.
A further aim of the present invention is to provide a stereoselective process for preparing the compound according to the invention.